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The US Food and Drug Administration is re-proposing a ban on electrical stimulation devices used to reduce or stop self-injury or aggressive behavior, the agency said. press release Monday.
Electrical stimulation devices deliver electrical shocks through electrodes attached to a person's skin in an attempt to reduce or stop harmful behaviors. The only facility in the U.S. currently using these devices is the Judge Rothenberg Education Center in Caton, Massachusetts, which said in a statement that approximately 50 people have treatment plans that include the use of the device.
The FDA said it took the unusual step of suspending a previously approved device because electrical stimulation devices “pose an unreasonable and substantial risk of illness or injury.”
This is the second time the FDA has proposed a ban on these devices. In 2020, the agency issued a final rule But it was regulation that banned the devices from the market. Canceled. After the Federal Court of Appeals Purchased The FDA did not have the authority to ban the devices under the federal Food, Drug, and Cosmetic Act.
Since that decision, changes to the law have made it clear that the FDA has the authority to issue such a ban, Monday's statement said.
The FDA said the devices “present a number of psychological risks, including depression, anxiety, exacerbation of underlying symptoms, post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”
“Specifically, some people who engage in self-injurious or aggressive behavior have intellectual or developmental disabilities that prevent them from communicating or making their own medical decisions,” the agency said.
The proposed ban would apply only to electrical stimulation devices intended for self-harm or assault, not to protective devices used for other purposes, such as smoking cessation, the agency said.
“Those exposed to these devices may need time to gradually transition from this device and adjust treatment plans. If we complete the proposed ban, the FDA intends to consider the needs of these patients,” he said.
Other behavioral treatments, such as positive behavioral support and medications, are alternative approaches to self-injurious or aggressive behaviors, according to the FDA in 2015. 2020.
of A new proposal It will be open for comment until May 28, after which FDA will review comments before deciding whether to issue a final rule.